Industry News: Thermo Fisher Scientific Signs New Agreements to Expand Oncomine Dx Target Test

Daiichi Sankyo and Takeda Pharmaceuticals to leverage FDA-approved test for clinical trials and drug development programs

11 May 2018

Thermo Fisher Scientific announced it has signed agreements with Takeda Pharmaceuticals and Daiichi Sankyo that will enable the Japanese firms to leverage Thermo Fisher’s FDA-approved Oncomine Dx Target Test for their clinical trials and drug development programs. The deal further expands the clinical utility of the next-generation sequencing (NGS)-based test to assess patient tumor samples for markers associated with cancer.

Thermo Fisher Scientific has signed new agreements with Daiichi Sankyo and Takeda Pharmaceuticals designed to expand the clinical utility of Oncomine Dx Target Test in support of clinical trials and drug development programs at each of the firms. The agreements will focus on validating additional biomarkers and gene variants on the test and support Thermo Fisher’s commitment to further enable precision oncology. Expansion of Oncomine Dx Target Test aligns with the company’s strategic plan to further develop its test as a companion diagnostic (CDx) for multiple therapies.

“We are extremely pleased with the strong interest and commitment from our pharmaceutical partners who see the value of leveraging the expandability of Oncomine Dx Target Test,” said Joydeep Goswami, president of Clinical Next Generation Sequencing and Oncology at Thermo Fisher Scientific. “This unique feature can help expedite their drug development programs so that patients potentially benefit more quickly from the targeted therapies in the development pipeline.” 

To date, Thermo Fisher has multiple active sPMA programs in place to expand Oncomine Dx Target Test, including an agreement announced by Spectrum Pharmaceuticals, and another to add the ALK gene, which is nearing completion. The company entered into CDx agreements with Agios Pharmaceuticals last year to validate the test to identify IDH1 mutations in cholangiocarcinoma patients, and with Blueprint Medicines to identify RET fusions in non-small cell lung cancer (NSCLC). 

Oncomine Dx Target Test is FDA approved to simultaneously report 23 genes clinically associated with NSCLC. Of those 23, three contain markers that are approved for use as a CDx for specific targeted therapies.  Since receiving FDA approval last year, the test has become available to more than 160 million lives in the United States. 


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